DAYTIME NIGHTTIME Cold and Flu

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:10

Label at a glance#

ProductDAYTIME NIGHTTIME Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each Softgel) (Daytime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 10mgCough suppressant
Phenylephrine HCl 5mgNasal Decongestant
Active ingredients (in each Softgel) (Nighttime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 15mgCough suppressant
Docylamine Succinate 6.25mgAntihistamine

OTC - PURPOSE SECTION

Daytime

Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

Nighttime

Pain reliever/fever reducer, Cough suppressant and Antihistamine

INDICATIONS & USAGE SECTION

* temporarily relieves common cold/flu symptoms:

  • nasal congestion (Daytime only)
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing (Nighttime only)

WARNINGS SECTION

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
*more than 4 doses in 24 hrs, which is the maximum daily amount for this product
* with other drugs containing acetaminophen
*3 or more alcoholic drinks every day while using this product

Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
*skin reddening
*blisters
*rash
If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
*with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
* if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

*to make a child sleep (Nighttime only).

Ask a doctor before use if you have

* liver disease
* heart disease (Daytime only)
* high blood pressure (Daytime only)
* thyroid disease (Daytime only)
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
* cough that occurs with too much phlegm (mucus)

Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)

When using this product
Do not use more than directed. In addition when using Nighttime:
* excitability may occur, especially in children
* marked drowsiness may occur
* alcohol, sedatives, and tranquilizers may increase drowsiness
* be careful when driving a motor vehicle or operating machinery
* avoid alcoholic drinks

Stop use and ask a doctor if
* you get nervous, dizzy, or sleepless (Daytime only)
* pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition

If pregnant or breast-feeding,
ask a health care professional before use.

Keep out of reach of children

OVERDOSE WARNING:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
OVERDOSE WARNING:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
* take only as directed - see OVERDOSE WARNING

* do not exceed 4 doses per 24 hrs
* take softgels with water

Read each label carefully before taking Daytime and Nighttime product

DaytimeNighttime
adulta & children age 12 years & over2 softgels every 4 hours2 softgels every 6 hours
children 4 to under 12 yearsask a doctorask a doctor
children under 4 yearsdo not usedo not use

OTHER SAFETY INFORMATION

Other information
* store at room temperature between 20 - 25°C (68 - 77°F)

*avoid excessive heat, cold and humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients (Daytime)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.


Inactive ingredients (Nightime)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime Nighttime Cold & FluDaytime Nighttime Cold & Flu

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN3
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN3
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-602-12DAYTIME NIGHTTIME Cold and Flu1 in 1 PACKAGE, COMBINATIONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-602DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [STRIVE PHARMACEUTICALS INC.]3Legacy NDC, 1 package rows20220413_7a027fdf-a69a-9cbf-e053-2a91aa0ac4d6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-60270692-602-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dc792803-726f-f48d-e053-2a95a90a73697a027fdf-a69a-9cbf-e053-2a91aa0ac4d62022-04-12WarningsExact identifier
spl id: dc792803-726f-f48d-e053-2a95a90a7369
spl set id: 7a027fdf-a69a-9cbf-e053-2a91aa0ac4d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.